VTI computer validation engineers will help ensure that your computerized systems are developed and qualified following a structured life cycle approach consistent with the Good Automated Manufacturing Practice (GAMP5) guidance.
A Proven Process that Benefits You
We have developed a process and a suite of services designed to ensure that you are in compliance with the applicable sections of the cGMP/GLP/GCP, 21 CFR Part 11, Annex 11 and Health Canada. This process will assure the quality of computerized systems through the development and/or execution of requirements, specifications, design, coding, testing, installation and acceptance. This process includes the following steps customized to your unique needs:
- Excel Spreadsheet Validation
- ERP, QMS, LIMS and other GXP software Program Validation
- Supplier/Vendor Audits
- Client Validation Life Cycle Audit
- 21 CFR Part 11 Audits/ Remediation Plans
- Policies & Procedures Development
- Software Validation
- Validation Plans
- IT Network Qualification
- Disaster Recovery Plans
- Operation & Security SOPs
- Change Management and Control
- System User Requirements and Design Documents
- Protocols, Test Plans, Test Scripts
- 21 CFR Part 11 Training
- Data Integrity, Data Classification and Data Control Assessment and implementation